NCT01470664

Brief Summary

This randomized, double masked, multi-center study is being conducted to support the safety and efficacy of FST-100 for the treatment of acute adenoviral conjunctivitis.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 17, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2014

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

November 9, 2011

Last Update Submit

June 23, 2021

Conditions

Acute Adenoviral Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Adenoviral eradication and clinical resolution of the infection

    6-7 days

Study Arms (3)

FST-100

EXPERIMENTAL
Drug: FST-100

FST-100 (Component #1)

EXPERIMENTAL
Drug: FST-100 (Component #1)

FST-100 Vehicle

PLACEBO COMPARATOR
Drug: FST-100 Vehicle

Interventions

FST-100DRUG

0.1% dexamethasone and 0.6% polyvinylpyrrolidone iodine (PVP-Iodine)

FST-100
FST-100 (Component #1)DRUG

0.6% PVP-Iodine ophthalmic solution alone

FST-100 (Component #1)
FST-100 VehicleDRUG

FST-100 Vehicle

FST-100 Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a clinical diagnosis of suspected acute adenoviral conjunctivitis in at least one eye.

You may not qualify if:

  • Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ora, Inc.

Andover, Massachusetts, 01810, United States

Location

Ora, Inc.

Noida, 201301, India

Location

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 11, 2011

Study Start

December 17, 2012

Primary Completion

May 23, 2014

Study Completion

May 23, 2014

Last Updated

June 25, 2021

Record last verified: 2021-06

Locations

US(1)IN(1)